Use of an interdisciplinary weight loss and lifestyle intervention in overweight or obese Spanish men with moderate to severe obstructive sleep apnea (OSA) who were receiving continuous positive airway pressure (CPAP) therapy was associated with clinically meaningful, sustainable improvements in severity of OSA and quality of life (QoL), according to clinical trial results recently published in JAMA Network Open.
The investigators for the Interdisciplinary Weight Loss and Lifestyle Intervention for OSA (INTERAPNEA) study (ClinicalTrials.gov Identifier: NCT03851653) sought to assess the effectiveness of an interdisciplinary weight loss and lifestyle intervention combined with usual care (ie, CPAP therapy) for treating men with moderate to severe OSA who were either overweight or obese. INTERAPNEA was a parallel-group, open-label, randomized clinical trial that was conducted at a hospital-based referral center in Granada, Spain, between April 1, 2019, and October 23, 2020.
A total of 89 men between 18 and 65 years of age with moderate to severe OSA and a body mass index of ≥25 kg/m2, all of whom were being treated with CPAP therapy, were enrolled in the study. The inclusion of only male participants was based on the higher incidence and prevalence of OSA in this patient population, as well as on the differences in OSA phenotypes among men vs women and the known effectiveness of weight loss interventions in men vs women.
The primary study endpoint was change in apnea-hypopnea index (API) from baseline to the intervention endpoint (at 8 weeks), as well as at 6 months following the intervention. Secondary endpoints included changes in other OSA sleep-associated outcomes, body weight/composition, health-related QoL (HRQoL), and cardiometabolic risk. All participants were randomized to treatment with CPAP (usual care) or to an 8-week weight loss intervention that included nutritional behavior, sleep hygiene, aerobic exercise, and alcohol/tobacco cessation, along with usual care.
A total of 89 men were enrolled in the study — 40 to the intervention group and 49 to the control group. All of the men were of Spanish ancestry. The mean participant age was 54.1±8.0 years. The mean AHI was 41.31±22.2 events per hour.
The investigators found a greater decrease in AHI reported in the intervention group (51% reduction; change, –21.2 events per hour; 95% CI, –25.4 to –16.9 events per hour) compared with the control group (change, 2.5 events per hour; 95% CI, –2.0 to –6.9 events per hour) at the intervention endpoint, with a mean between-group difference of –23.8 events per hour (95% CI, –28.3 to –19.3 events per hour).
At 6 months following the intervention, the reduction in AHI was 57% in the intervention arm, with a mean between-group difference of –23.89 events per hour (95% CI, –28.3 to –19.3 events per hour). Additionally, in the intervention arm, 45.0% (18 of 40) of the participants no longer required CPAP therapy at the intervention endpoint, with 15.0% (6 of 40) of the participants achieving complete OSA remission.
Also at 6 months after the intervention, 61.8% (21 of 34) of the participants no longer needed to receive CPAP therapy, with complete remission of OSA achieved by 29.4% (10 of 34) of participants.
When comparing the intervention vs the control arms, significantly greater improvements in the following were observed at the intervention endpoint: (1) body weight (change, –7.1 kg [95% CI, –8.6 to –5.5 kg] vs –0.3 kg [95% CI, –1.9 to 1.4 kg], respectively); (2) body composition (change in fat mass, –2.9 kg [95% CI, –4.5 to –1.3 kg] vs 1.4 kg [95% CI, –0.3 to 3.1 kg], respectively); (3) cardiometabolic risk (change in blood pressure, –6.5 mm Hg [95% CI, –10.3 to –2.6 mm Hg] vs 2.2 mm Hg [95% CI, –2.1 to 6.6 mm Hg], respectively); and (4) HRQoL (change in Sleep Apnea Quality of Life Index, 0.8 points [95% CI, 0.5 to 1.1 points] vs 0.1 points [95% CI, –0.3 to 0.4 points], respectively).
A major limitation of INTERAPNEA is its sole inclusion of men in the study sample. Thus, the generalizability of any findings is confined to this patient population. Moreover, because the sample included Spanish participants only, study results are thus restricted to this ethnic group.
The investigators concluded that the approach evaluated in the current study may be considered as a central strategy for tackling the substantial impact of OSA on the health and welfare of various patient populations.
Carneiro-Barrera A, Amaro-Gahete FJ , Guillén-Riquelme A, et al. Effect of an interdisciplinary weight loss and lifestyle intervention on obstructive sleep apnea severity: the INTERAPNEA randomized clinical trial. JAMA Netw Open. Published online April 22, 2022. doi:10.1001/jamanetworkopen.2022.8212
This article originally appeared on Pulmonology Advisor